Gastric bypass devices and procedures

ABSTRACT

Methods and devices for treating obesity are provided, and more particularly, methods and devices for performing gastric bypasses are disclosed. In one exemplary embodiment a gastric bypass procedure is provided that includes forming a gastro-entero anastomosis between a stomach and an intestine and forming an entero-entero anastomosis between a portion of the intestine distal to the gastro-entero anastomosis and a portion of the intestine proximal to the gastro-entero anastomosis. A surrogate path is formed between the esophagus and the gastro-entero anastomosis to at least partially direct fluid from the esophagus to the intestine by way of the gastro-entero anastomosis, thereby bypassing the stomach. Still further, methods for repairing an abdominal aortic aneurysm and leaking heart valve are also disclosed.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a divisional of U.S. patent application Ser.No. 12/266,174, filed on Nov. 6, 2008, and entitled “GASTRIC BYPASSDEVICES AND PROCEDURES,” which is hereby incorporated herein byreference in its entirety.

The present application relates to surgical procedures, and moreparticularly to methods for performing a gastric bypass.

BACKGROUND

The percentage of the world population suffering from morbid obesity issteadily increasing. Some estimates show the number of people thatsuffer from morbid obesity in the United States alone exceeds 10million, and the deaths of an estimated 500,000 people could be relatedto obesity. Severely obese people are susceptible to an increased riskof many medical conditions, including heart disease, stroke, diabetes,pulmonary disease, hypertension, gall bladder disease, osteoarthritis,sleep apnea and other breathing problems, some forms of cancer (e.g.,uterine, breast, colorectal, kidney, and gall bladder), accidents, anddeath.

Surgical treatment options for treating obesity are growing and beingperformed at an increasing rate. These approaches can generally becategorized as either malabsorptive or restrictive. Absorptiveprocedures modify the gastrointestinal tract so that only a smallfraction of the food and fluid intake is actually digested; restrictiveprocedures limit an amount of food and fluid intake. Following arestrictive procedure, a patient's ability to eat is severelyrestricted. The patient can only eat a limited amount of food and fluidand any attempt to eat more will result in varying degrees ofdiscomfort.

A leading surgical approach for treating obesity is often referred to asthe Roux-en-Y gastric bypass procedure. A Roux-en-Y procedure combinesrestrictive and malabsorptive approaches by restricting the stomach andbypassing a proximal portion of the small intestine. The stomach istypically restricted by stapling at least a portion of the stomach tocreate a pouch, effectively limiting the size of a patient's stomach andthereby limiting a patient's food and fluid intake. Staple linefailures, however, are a known problem of Roux-en-Y gastric bypassprocedures. When a staple line fails, the patient can regain weight. Italso can cause the body to be exposed to undesirable outside materials,such as stray staples. To prevent staple line failure, some surgeonspractice additional techniques to make the division more secure, forexample by suturing off the pouch from the portion of the stomach thatis to remain a part of the digestive tract. The creation of pouches,however, is not generally desirable because they can result in stenosis,e.g., stricture of the stomach stoma that can have a major effect on apatient's eating, and dilation, e.g., stretching of the stomach that canresult in weight gain. It is currently believed that about 5 to 10percent of Roux-en-Y patients have dilation problems and about 2 percenthave intestinal obstruction. Further, metabolic complications can alsooccur following a Roux-en-Y procedure, such as anemia and calciumdeficiency, because essential vitamins and nutrients of blood production(e.g., iron and vitamin B12) depend on the stomach and intestine forabsorption, and because calcium is best absorbed in the duodenum, whichis bypassed in a Roux-en-Y procedure. Still further, current procedureslike Roux-en-Y are difficult to adjust and impossible to reverse,despite the fact that it can be desirable to make adjustments to thegastric bypass for the patient or even reverse the gastric bypassentirely.

It is thus desirable to provide a new surgical procedure for treatingobesity that does not create pouches in the stomach, does not usestaples, and which can be easily adjusted or even reversed.

Further, mitral regurgitation is the most prevalent form of valvularheart disease. Surgical therapy for mitral valve regurgitation is commonwith approximately 20,000 procedures performed in the United States eachyear. Operative strategies and techniques have progressed significantlysince the early experience with emphasis on mitral valve repair insteadof replacement. Subsequently, the mortality rate for surgical mitralvalve repair is now less than 5% and lasting results (freedom fromre-operation), particularly when treating primary mitral regurgitationare reported to be greater than 90% at five years at follow-up.Recently, a new paradigm has emerged for the treatment of mitralregurgitation. This is based on percutaneous techniques and theexperiences of both cardiac surgeons and interventional cardiologists.

It is thus also desirable to provide new surgical procedures forrepairing a heart valve.

SUMMARY

The present invention generally provides methods for treating obesity.In one embodiment, a method for forming a gastric bypass includesforming an anastomosis between first and second portions of anintestine, e.g., an entero-entero anastomosis, to form a loop in theintestine, forming an anastomosis between the loop and the stomach,e.g., a gastro-entero anastomosis, and implanting a shunt in thestomach. The shunt is generally configured to at least partially directa fluid passing therethrough from the esophagus through thegastro-entero anastomosis. The fluid can be directed in a number ofdifferent directions upon passing through the gastro-entero anastomosis,including to only a first portion of the loop that is proximal to thegastro-entero anastomosis, to only a second portion of the loop that isdistal to the gastro-entero anastomosis, or to both the first and secondportions of the loop. An anastomotic device can be implanted in eitheror both the gastro-entero anastomosis and the entero-entero anastomosis.The anastomotic device can include a connector, and the method caninclude adjusting a length of the connector extending between a proximalend and a distal end of the anastomotic device. The length can beadjusted in a variety of ways, for example, by rotating a rod disposedbetween the proximal and distal ends of the anastomotic device. In oneembodiment, the anastomotic device includes a proximal tubular body anda distal tubular body, and a length of the connector can be adjusted bypositioning the proximal tubular body along a portion of the distaltubular body. Further, implanting one or more anastomotic devices can beperformed in a variety of ways, but in one embodiment implanting thedevice can include coupling an anastomotic device to at least a portionof an actuator that is used to deploy the anastomotic device usingsutures. In another embodiment, implanting the anastomotic device caninclude coupling the device to at least a portion of an actuator that isused to deploy the anastomotic device by locking the anastomotic deviceto the actuator. In still another embodiment, implanting the anastomoticdevice can include breaking apart a portion of an actuator used todeploy the anastomotic device to remove the actuator from theanastomotic device. The shunt can be configured to pass through theanastomotic device at the gastro-entero anastomosis, or alternatively,the shunt can include an anastomotic device integrally formed thereon.Further, implanting the shunt can include inserting an endoscope throughthe shunt and manipulating the endoscope to advance a delivering shaftcoupled to the shunt along a tortuous pathway. The shunt can include aone-way valve that is configured to inhibit acid reflux.

In one embodiment the gastro-entero anastomosis can be formed prior toforming the entero-entero anastomosis. In such an embodiment, ananastomosis-forming device can be passed through the gastro-enteroanastomosis to form the entero-entero anastomosis. In another embodimentthe entero-entero anastomosis can be formed prior to forming thegastro-entero anastomosis. In such an embodiment, an anastomosis-formingdevice can be used to form the gastro-entero anastomosis prior toremoving the anastomosis-forming device from the surgical site. Thegastric bypass can also be reversed, for example, by removing the shunt.

In another embodiment of a method for forming a gastric bypass, aportion of an intestine can be positioned adjacent to a stomach and afluid connection can be formed therebetween. A surrogate path from anesophagus to a distal portion of the intestine, by way of the connectionbetween the portion of the intestine and the stomach, can be formed suchthat fluid is at least partially directed from the esophagus to theintestine through the connection. The formation of the surrogate pathallows the stomach to be bypassed. The method can also include forming aconnection between the distal portion of the intestine and a proximalportion of the intestine, which is the portion of the intestine proximalto the connection between the stomach and the intestine. The surrogatepath can extend to the proximal portion of the intestine, in addition toor in lieu of extending to the distal portion of the intestine, by wayof the connection between the intestine and the stomach. The connectionbetween the stomach and the intestine can be formed by implanting afirst anastomotic device therebetween. The connection between theproximal and the distal portions of the intestine can be formed byadvancing a second anastomotic device through the first anastomoticdevice and implanting the second anastomotic device between the proximaland distal portions of the intestine. The surrogate path can be formedby implanting a shunt to extend between the esophagus and the connectionbetween the stomach and the intestine. The shunt can be implanted, forexample, by transorally advancing an endoscope having a delivery shaftcoupled to the shunt disposed therearound. In one embodiment the shuntincludes an anastomotic device formed thereon that can be implantedbetween the stomach and the intestine to form the fluid connectiontherebetween. The gastric bypass can be reversed, for example, byremoving the surrogate path.

In another embodiment of a method for treating obesity an elongatemember can be implanted in the stomach such that the elongate memberextends from the esophagus and through an anastomosis formed between thestomach and an intestine. The elongate member can at least partiallydivert fluid from the esophagus to the intestine, which in turn bypassesthe stomach and at least a portion of the intestine proximal to theanastomosis. The method can further include forming a second anastomosisbetween a proximal portion of the intestine, which is the portion of theintestine proximal to the anastomosis formed between the stomach and theintestine, and a distal portion of the intestine, which is the portionof the intestine distal to the anastomosis formed between the stomachand the intestine. The method for treating obesity can be reversed, forexample, by removing the elongate member.

The present invention also provides for a variety of anastomotic devicesthat can be used to help form anastomoses. In one embodiment of ananastomotic device, the device includes a first tubular body and asecond tubular body. The first tubular body can include a proximal endand a distal end, and the distal end can be adapted to expand uponrotation to form distal wings. The second tubular body can include adistal end that can be slidably coupled to the proximal end of the firsttubular body and a proximal end that can be adapted to expand uponrotation to form proximal wings that extend toward the distal wings ofthe first tubular body to engage tissue therebetween. The distal end ofthe first tubular body and the proximal end of the second tubular bodycan include a plurality of asymmetrical substantially s-shaped slitsthat are formed therein. Further, the first and second tubular bodiescan each include a lumen formed therethrough such that the lumens areconfigured to form a passageway through tissue. In one embodiment eachof the first and second tubular bodies are formed from a non-permeablematerial. The first and second tubular bodies can be configured suchthat they form a shunt. The shunt can include a proximal end that isadapted to receive a fluid and a distal end that is configured to directfluid in a single direction, or alternatively, in a plurality ofdirections.

In another embodiment of an anastomotic device, the device can include afirst tubular body and a second tubular body. The first tubular body caninclude an elongate proximal end and a distal end that is adapted toexpand upon rotation to form distal wings. The second tubular body caninclude a proximal end that is adapted to expand upon rotation to formproximal wings that extend toward the distal wings of the first tubularbody to engage tissue therebetween and a distal end that is adapted tobe selectively positioned along the elongate proximal end of the firsttubular body. The distal end of the first tubular body and the proximalend of the second tubular body can include a plurality of asymmetricalsubstantially s-shaped slits formed therein. Further, the first andsecond tubular bodies can each include a lumen formed therethrough suchthat the lumens are configured to form a passageway through tissue. Inone embodiment each of the first and second tubular bodies are formedfrom a non-permeable material. The first and second tubular bodies canbe configured such that they form a shunt. The shunt can include aproximal end that is adapted to receive a fluid and a distal end that isconfigured to direct fluid in a single direction, or alternatively, in aplurality of directions.

The present invention also includes methods for repairing an abdominalaortic aneurysm. In one exemplary embodiment, the method includespositioning a dome over a fenestration in an aorta to place ananastomotic device coupled to a first artery in fluid communication witha second artery disposed on an opposite site of the aorta. The methodcan further include placing a vascular conduit having a fenestration inthe aorta such that the dome is positioned over the fenestration in thevascular conduit.

BRIEF DESCRIPTION OF DRAWINGS

This invention will be more fully understood from the following detaileddescription taken in conjunction with the accompanying drawings, inwhich:

FIG. 1 is a side view of one exemplary embodiment of an anastomoticdevice in an initial, unformed configuration;

FIG. 2 is an end view of the anastomotic device of FIG. 1 prior todeployment;

FIG. 3 is an end view of the anastomotic device of FIG. 1 followingdeployment;

FIG. 4 is a side view of the anastomotic device of FIG. 1 followingdeployment;

FIG. 5 is a cross-sectional view of the anastomotic device of FIG. 4following deployment;

FIG. 6 is a perspective view of another exemplary embodiment of ananastomotic device in an initial, unformed configuration;

FIG. 7 is a perspective cross-sectional view of the anastomotic deviceof FIG. 6;

FIG. 8 is a perspective cross-sectional view of the anastomotic deviceof FIG. 6 following deployment;

FIG. 9 is a side cross-sectional view of the anastomotic device of FIG.8 following deployment;

FIG. 10 is a perspective view of the anastomotic device of FIG. 6following deployment;

FIG. 11 is a perspective view of another exemplary embodiment of ananastomotic device in an initial, unformed configuration;

FIG. 12 is a perspective cross-sectional view of the anastomotic deviceof FIG. 11;

FIG. 13 is a side cross-sectional view of the anastomotic device of FIG.11;

FIG. 14 is a perspective view of the anastomotic device of FIG. 11following deployment;

FIG. 15 is a perspective cross-sectional view of the anastomotic view ofFIG. 14 following deployment;

FIG. 16 is a perspective view of one exemplary embodiment of an actuatorfor deploying an anastomotic device, showing an anastomotic devicecoupled thereto;

FIG. 17 is a side view of the anastomotic device of FIG. 16 and a distalportion of the actuator of FIG. 16;

FIG. 18 is a cross-sectional view of the anastomotic device and theinner shaft of FIG. 17;

FIG. 19 is a cross-sectional view of the handle portion of the actuatorof FIG. 16;

FIG. 20 is a perspective view of a proximal portion of the actuator ofFIG. 19 in an initial, starting position;

FIG. 21 is a perspective view of the proximal portion of the actuatorshown in FIG. 20 following deployment of the distal wings of ananastomotic device;

FIG. 22 is a perspective view of the proximal portion of the actuatorshown in FIG. 21 following deployment of the proximal wings of theanastomotic device;

FIG. 23 is a side view of the anastomotic device of FIG. 16 and an innershaft of the actuator of FIG. 16 being removed from the anastomoticdevice;

FIG. 24 is a side view of the anastomotic device of FIG. 23 and a distalgripper assembly of the actuator being removed from the anastomoticdevice;

FIG. 25 is a side view of the anastomotic device of FIG. 24 and theremainder of the actuator being removed from the anastomotic device;

FIG. 26 is a perspective view of one exemplary embodiment of a former ofan actuator for deploying an anastomotic device, showing the anastomoticdevice of FIG. 16 coupled thereto in an initial, unformed configuration;

FIG. 27 is a cross-sectional perspective view of the anastomotic deviceand the inner shaft of FIG. 26;

FIG. 28 is a cross-sectional perspective view of the anastomotic deviceand the inner shaft of FIG. 27 following deployment;

FIG. 29 is a cross-sectional perspective view of the anastomotic deviceand the inner shaft of FIG. 28 following deployment with suturesremoved;

FIG. 30 is a perspective view of the anastomotic device followingdeployment with the former and inner shaft de-coupled therefrom;

FIG. 31 is a perspective view of another exemplary embodiment of aformer of an actuator for deploying an anastomotic device, showing theanastomotic device of FIG. 1 coupled thereto in an initial, unformedconfiguration;

FIG. 32 is a cross-sectional side view of the anastomotic device and aninner shaft of the former of FIG. 31;

FIG. 33 is a cross-sectional perspective view of the anastomotic deviceand the inner shaft of FIG. 31 following deployment;

FIG. 34 is a cross-sectional perspective view of the anastomotic deviceand the inner shaft of FIG. 33 following deployment with the former andthe inner shaft being removed;

FIG. 35 is a cross-sectional perspective view of the anastomotic deviceand the inner shaft of FIG. 34 following deployment with the former andthe inner shaft de-coupled therefrom;

FIG. 36 is a perspective view of another exemplary embodiment of aformer of an actuator for deploying an anastomotic device, showing theanastomotic device of FIG. 11 coupled thereto in an initial, unformedconfiguration;

FIG. 37 is a cross-sectional perspective view of the anastomotic deviceand an inner shaft of the former of FIG. 36;

FIG. 38 is a perspective view of the anastomotic device of FIG. 37following deployment;

FIG. 39 is a perspective view of another exemplary embodiment of aformer of an actuator for deploying an anastomotic device, having aforced release mechanism disposed therein, showing the anastomoticdevice of FIG. 1 coupled to both the former and the forced releasemechanism and in a deployed configuration;

FIG. 40 is a cross-sectional perspective view of the anastomotic device,the former, and the forced release mechanism of FIG. 39;

FIG. 41 is a perspective view of the forced release mechanism of FIG. 40

FIG. 42 is a perspective view of the anastomotic device, the former, andthe forced release mechanism of FIG. 40 with the former and the forcedrelease mechanism de-coupled from the anastomotic device;

FIG. 43 is a side view of one exemplary embodiment of a shunt having ananastomotic device integrally formed thereon;

FIG. 44 is a side view of another exemplary embodiment of a shunt havingan anastomotic device integrally formed thereon;

FIG. 45A is a schematic view of one exemplary embodiment of a method fortreating obesity that includes forming openings in a stomach and anintestine and disposing an endoscope in a distal portion of theintestine;

FIG. 45B is a schematic view of the method of FIG. 45A that includesforming openings in a proximal portion and the distal portion of theintestine, forming an entero-entero anastomosis between the openings ofthe proximal and distal portions of the intestine, and deploying ananastomotic device in the entero-entero anastomosis;

FIG. 45C is a close-up schematic view of the method of FIG. 45B taken atthe location of the entero-entero anastomosis showing the anastomoticdevice deployed between the openings in the proximal and distal portionsof the intestine;

FIG. 45D is a schematic view of the method of FIG. 45B that includesretracting the endoscope from the distal portion of the intestine,forming a gastro-entero anastomosis between the openings in the stomachand the intestine and deploying an anastomotic device in thegastro-entero anastomosis;

FIG. 45E is a close-up schematic view of the method of FIG. 45D taken atthe location of the gastro-entero anastomosis showing the anastomoticdevice deployed between the openings in the stomach and the intestine;

FIG. 45F is a schematic view of the method of FIGS. 45A-45E with theendoscope removed from the body and illustrating the resultingconfiguration of the stomach and the intestine;

FIG. 45G is a schematic view of the shunt of FIG. 43 implanted in astomach to deliver fluid from an esophagus to a gastro-enteroanastomosis;

FIG. 45H is a schematic view of the shunt of FIG. 44 implanted in astomach to deliver fluid from an esophagus to a gastro-enteroanastomosis;

FIG. 46 is perspective view of one exemplary embodiment of anendovascular graft having the device of FIG. 11 associated therewith;

FIG. 47 is a side view of the graft of FIG. 46;

FIG. 48 is a schematic view of one exemplary embodiment of a heart valverepair having the device of FIG. 11 associated therewith; and

FIG. 49 is a schematic view of another exemplary embodiment of a heartvalve repair having the device of FIG. 11 associated therewith.

DETAILED DESCRIPTION

Certain exemplary embodiments will now be described to provide anoverall understanding of the principles of the structure, function,manufacture, and use of the devices and methods disclosed herein. One ormore examples of these embodiments are illustrated in the accompanyingdrawings. Those skilled in the art will understand that the devices andmethods specifically described herein and illustrated in theaccompanying drawings are non-limiting exemplary embodiments and thatthe scope of the present invention is defined solely by the claims. Thefeatures illustrated or described in connection with one exemplaryembodiment may be combined with the features of other embodiments. Suchmodifications and variations are intended to be included within thescope of the present invention.

The present invention provides methods and devices for treating obesityby way of a gastric bypass procedure. The methods generally involve theformation of a surrogate path that extends between a patient's esophagusand an anastomosis formed between the patient's stomach and intestine.In an exemplary embodiment, the surrogate path can be formed with ashunt that is effective to allow fluid that passes therethrough tobypass the patient's stomach. The term fluid is used herein to generallyrefer to any material that can pass through a patient's esophagus,including but not limited to food, liquid, and other materials that canpass through a digestive system. The disclosed methods are particularlyadvantageous as they do not involve stapling or any other sectioning offof one portion of the stomach from another such that only a portion ofthe stomach receives fluid. The methods are also reversible tocompletely eliminate the gastric bypass based on the needs of thepatient. The present methods are particularly conducive to NaturalOrifice Translumenal Endoscopic Surgery (NOTES) procedures, making theprocedure less painful for patients, although other types of procedures,such as laparoscopic and open procedures, can also be used to performthe present methods.

As indicated above, in general the disclosed methods for forming agastric bypass can include forming at least one anastomosis. Theanastomosis can be formed in a variety of different ways using a varietyof instruments. Because an anastomosis involves joining two spaces thatare not normally connected to allow fluid to flow therethrough, varioustools and implants known in the art can be used to form the anastomosis.Exemplary embodiments of anastomotic devices and methods for forminganastomoses are disclosed in U.S. patent application Ser. No. 11/876,131of Coleman et al., filed on Oct. 22, 2007, and entitled “Anastomoticdevices and Methods,” (hereinafter “the '131 Application”) which ishereby incorporated by reference in its entirety.

FIGS. 1-5 illustrate one exemplary embodiment of an anastomotic device10 that can be used to form an anastomosis. As shown, the device 10 isin the form of a generally elongate tubular body 12 with an openproximal end 10 a and an open distal end 10 b. The device 10 furtherincludes proximal and distal portions 12 a, 12 b that are configured toexpand to engage tissue therebetween. As illustrated in the un-deployeddevice 10 of FIG. 1, the proximal and distal portions 12 a, 12 b eachinclude a plurality of slits 14 a, 14 b formed therein and configured toallow portions of the elongate tubular body 12 between the plurality ofslits 14 a, 14 b to radially expand. A mid-portion 13 of the tubularbody 12, located between the proximal and distal portions 12 a, 12 b,can be configured to be positioned between two cut body lumens, e.g.,within an anastomosis. The mid-portion 13 can have a fixed or adjustablelength that corresponds to a thickness of the tissue walls. Whenimplanted, the device 10 is generally configured to form a solidconnection between two distinct spaces within the body, e.g., thestomach and the intestine or two portions of the intestine.

The slits 14 a, 14 b in the proximal and distal portions 12 a, 12 b canextend in any direction, and each portion 12 a, 12 b can include anynumber of slits. Preferably, the slits 14 a, 14 b are configured suchthat certain portions of the elongate tubular body 12 between the slits14 a, 14 b will extend outward away from a central axis A of the tubularbody 12 when the body 12 is axially compressed, and preferably rotatedas well. As a result, one or more wings will form in each of the distaland proximal portions 12 a, 12 b to engage tissue therebetween. Thedevice 10 can also include tabs 15 a in the proximal portion 12 a to aidin forming the wings, as discussed further below. Tabs can likewise beformed in distal portion 12 b if desired. In an exemplary embodiment, asshown in FIG. 1, the slits 14 a, 14 b are substantially S-shaped. Theslits 14 a, 14 b can extend longitudinally along the elongate tubularbody 12 in a proximal-distal direction, and they can be spaced axiallyaround the elongate tubular body 12. More preferably, the slits 14 a inthe distal portion 12 a can extend in a first direction around acircumference of the elongate tubular body 12 and the slits 14 b in theproximal portion 12 b can extend in a second, opposite direction aroundthe circumference of the elongate tubular body 12. Such a configurationallows the tubular body 12 to be rotated in a first direction to causeonly one of the proximal and distal portions 12 a, 12 b to radiallyexpand, and then to be rotated in a second direction to cause the otherone of the proximal and distal portions 12 a, 12 b to radially expand.

FIGS. 2 and 3 show distal end views of the device 10 in its pre-deployedconfiguration and following partial or full deployment, respectively. Inthe pre-deployed configuration shown in FIG. 2, the elongate tubularbody 12 has a diameter that is configured to fit within a body lumen intissue, e.g., through an opening in the stomach and/or in the intestine,and that may be configured to fit within an introducer sheath forguiding the device 10 to an anastomotic site. FIG. 3 illustrates thedistal portion 12 b radially expanded to form the distal wings. When theproximal portion 12 a is radially expanded to form the proximal wings,the proximal wings can be aligned with the distal wings to facilitatelumen joining. In such a case, the distal end view of the device 10would look as shown in FIG. 3 both before and after deployment of theproximal wings. The proximal wings can also be offset radially from thedistal wings. In the illustrated embodiment, the slits 14 a, 14 b areconfigured such that the proximal and distal portions 12 a, 12 b eachinclude six wings, however the proximal and distal portions can includeany number of wings.

FIG. 4 shows the anastomotic device 10 in a deployed configuration. Inthe deployed configuration, the proximal portion 12 a is expanded toform proximal wings 16 a, and the distal portion 12 b is expanded toform distal wings 16 b. The wings 16 a, 16 b are formed by the materialbetween the slits 14 a, 14 b, which is deformed outward as the outerelongate body 12 is compressed and preferably rotated. The wings 16 a,16 b can be concurrently or sequentially formed, e.g., deploying thedistal wings 16 b before the proximal wings 16 a.

FIG. 5 shows a cross-sectional view of the deployed device 10 of FIG. 4.The asymmetric profile of the slits 14 a, 14 b can allow the wings 16 a,16 b to form such that interior base bend angles α1, α2 are less thanrespective exterior base bend angles β1, β2. As a result, the wings 16a, 16 b will also extend toward one another. The interior based bendangles α1, α2 can be the same or different in the proximal and distalportions 12 a, 12 b, as can the exterior base bend angles β1, β2. If theexterior base bend angles β1, β2 are each about 90 degrees, the wings 16a, 16 b extend substantially parallel to each other, while acute andobtuse exterior base bend angles β1, β2 can allow the wings 16 a, 16 bto be angled toward each other at one end and away from each other atthe opposite end.

The tubular body 12 can be formed from a variety of materials includingabsorbable and non-absorbable materials. In an exemplary embodiment, thedevice 10 is formed from a deformable material that undergoes plasticdeformation (i.e., deformation with negligible elastic component).Exemplary materials include, by way of non-limiting example, anyresorbable (e.g., biocompatible and/or bioabsorbable) materials,including, for example, titanium (and titanium alloys), magnesiumalloys, stainless steel, polymeric materials (synthetic and/or natural),shape memory material such as nitinol, ceramic, etc. Materials which arenot normally radiopaque, e.g., magnesium alloy, may be enhanced and madex-ray visible with the addition of x-ray visible materials, such asparticles of iron oxide, stainless steel, titanium, tantalum, platinum,or any other suitable equivalents. Further, the materials discussedbelow with respect to the shunts can also be used to form and/or coatthe tubular body 12, including non-permeable materials, such aspolyethylene terephthalate and polyvinylidene chloride, andsemi-permeable materials, such as polylactide.

FIGS. 6-10 illustrate another exemplary embodiment of an anastomoticdevice 310 that can be used to form an anastomosis. The device 310 isconfigured to have an adjustable length. As shown, the device 310 is inthe form of two separate elongated tubular bodies 311, 312, with openproximal ends 311 a, 312 a and open distal ends 311 b, 312 b. Theproximal end 311 a of tubular body 311 can be configured to couple withthe distal end 312 b of tubular body 312, while the distal end 311 b oftubular body 311 and the proximal end 312 a of tubular body 312 can beconfigured to expand to engage tissue therebetween. As illustrated inthe un-deployed device 310 of FIG. 6, the distal end 311 b and theproximal end 312 a each include a plurality of slits 314 b, 314 a,respectively, formed therein and configured to allow portions of therespective elongate tubular bodies 311, 312 between the plurality ofslits 314 b, 314 a to radially expand. In the illustrated embodiment theslits 314 a, 314 b are substantially S-shaped to expand in a radialdirection and form wings 316 b, 316 a, as shown in FIGS. 8-10. As alsoillustrated in the un-deployed device 310 of FIG. 6, the proximal end311 a and the distal end 312 b each include a plurality of tabs 315,317, respectively. Disposed between each of tabs 315, 317 are notches319, 321, respectively. The tabs 315, 317 can be configured to matewithin the notches 319, 321 of the respective tubular bodies 311, 312 asshown, thereby forming an interlocking relationship between the tubularbodies 311, 312. The notches 319, 321 allow the tabs 315, 317 to slideaxially within the notches 319, 321, which in turn allows the tubularbodies 311, 312 to slide axially relative to each other to provide avariable length. In one embodiment, the proximal end 312 a of thetubular body 312 includes tabs 323 to assist with the introduction ofthe tubular bodies 311, 312 to the anastomosis. A person having ordinaryskill in the art would recognize that in other embodiments tabs 323 canbe formed in the tubular body 311 in a similar manner for a similarpurpose. Further, a person having ordinary skill in the art wouldrecognize that the tubular bodies 311, 312 can be coupled together in avariety of ways that allow for the tubular bodies 311, 312 to slideaxially to provide a variable length, and that such ways can be used tocouple the tubular bodies 311, 312 together. In some embodiments, threeor more tubular embodiments may be desirable. Although bodies 311, 312are discussed as being tubular, a person having ordinary skill in theart would recognize that other shapes can also be used to faun thebodies 311, 312.

As seen in FIGS. 7-9, a threaded insert 331, 332 can be disposed withineach tubular body 311, 312, respectively. In one embodiment threadedinsert 331 is a left-hand threaded insert and threaded insert 332 is aright-hand threaded insert. Both inserts 331, 332 can be coupled to therespective tubular bodies, for example by welding. A link rod 334 can bedisposed within the threaded inserts 331, 332 and it can be configuredto integrate the tubular bodies 311, 312. More particularly, the linkrod 334 can include threads that correspond to the respective threads ofthe inserts 331, 332 such that movement of the tubular bodies 311, 312are restricted. A key 336 can be disposed on one end of the link rod 334and it can be any shape, but in the illustrated embodiment the key 336is hexagonal. The key 336 can be engaged externally by a shaft of anagreeable shape to rotate the link rod 334 clockwise orcounter-clockwise as desired to adjust a gap 338 of the device 310. Moreparticularly, the threads of the inserts 331, 332 are configured toallow the tubular bodies 311, 312 to move toward each other when the key336 is rotated in one direction, thereby decreasing the size of the gap338, and away from each other when the key 336 is rotated in a seconddirection, thereby increasing the size of the gap 338. FIG. 10illustrates the device 310 in its final form. In particular, the wings316 a, 316 b of the tubular bodies 311, 312 have been deployed and thegap 338 adjusted to a desired length.

Another exemplary embodiment of an anastomotic device 410 is illustratedin FIGS. 11-15. The device 410 is configured to have an adjustablelength. As shown, the device 410 is in the form of two separateelongated tubular bodies 411, 412 that couple together to form aconnector 438 therebetween. The connector 438 can be adjusted, forexample, to match a thickness of tissue wall. In one embodiment, adiameter of tubular body 411 is smaller than a diameter of tubular body412 and a length of tubular body 411 is longer than tubular body 412. Asillustrated in the un-deployed device 410 of FIG. 11, tubular body 411has a distal portion 411 c configured to radially expand, anintermediate portion 411 b, and a proximal portion 411 a configured toallow a longitudinal position of tubular body 412 to be adjustedrelative to tubular body 411. The distal portion 411 c can include aplurality of slits 414 c formed therein and configured to allow portionsof the elongate tubular body 411 between the plurality of slits 414 c toradially expand. In the illustrated embodiment the slits 414 c aresubstantially S-shaped to expand in a radial direction and form wings416 c, as shown in FIGS. 14 and 15. The intermediate portion 411 b canbe flexible. In the illustrated embodiment, slits 413 are formed thereinto provide desired flexibility. The slits can be in a variety ofpatterns and can be formed in a variety of manners, for example, bylaser-cutting. As shown in FIG. 12, the proximal portion 411 a caninclude a plurality of slots 415 formed therein and configured toposition the tubular body 412 with respect to the proximal portion 411a. The slots 415 can be any shape and size, including curved, and can beformed using a variety of manners, for example by laser-cutting.

Tubular body 412 can be configured to slide over at least a portion ofthe proximal portion 411 a of tubular body 411. Tubular body 412 has adistal portion 412 c configured to engage the slots 415 of the proximalportion 411 a of tubular body 411 and a proximal portion 412 aconfigured to radially expand. The proximal portion 412 a can include aplurality of slits 414 a formed therein and configured to allow portionsof the elongate tubular body 412 between the plurality of slits 414 a toradially expand. In the illustrated embodiments the slits 414 a aresubstantially S-shaped to expand in a radial direction and form wings416 a, as shown in FIGS. 14 and 15. The distal portion 412 b can includeone or more flaps 419 configured to engage the slots 415 of the tubularbody 411. In the illustrated embodiment of FIG. 13, the flaps 419 arebent in an inward direction toward the slots 415 such that the tubularbody 412 can move toward the tubular body 411 and can lock in place whenmoved away from the tubular body 411. A person having ordinary skill inthe art would recognize that a variety of other configurations can beused to allow tubular body 412 to be fixed in various positions alongthe proximal portion 411 a of tubular body 411, including embodiments inwhich tubular body 412 can be moved in either direction with respect totubular body 411. In one embodiment, the proximal portion 412 a oftubular body 412 includes tabs 423 to assist with the introduction ofthe tubular bodies 411, 412 to the anastomosis. A person having ordinaryskill in the art would recognize that in other embodiments tabs 423 canbe formed in tubular body 411 in a similar manner for a similar purpose.FIGS. 14 and 15 illustrates the device 410 in its final form. Inparticular, the wings 416 c, 416 a of the tubular bodies 411, 412 havebeen deployed and the connector 438 adjusted to a desired length bysetting a position of tubular body 412 with respect to the proximalportion 411 a of tubular body 411. Although bodies 411, 412 arediscussed as being tubular, a person having ordinary skill in the artwould recognize that other shapes can also be used to form the bodies411, 412.

Similar to the tubular body 12, each of the tubular bodies 311, 312,411, and 412 can be formed from a variety of materials includingabsorbable and non-absorbable materials. In an exemplary embodiment, thedevices 310, 410 are formed from a deformable material that undergoesplastic deformation (i.e., deformation with negligible elasticcomponent). Exemplary materials include, by way of non-limiting example,any resorbable (e.g., biocompatible and/or bioabsorbable) materials,including, for example, titanium (and titanium alloys), magnesiumalloys, stainless steel, polymeric materials (synthetic and/or natural),shape memory material such as nitinol, ceramic, etc. Materials which arenot normally radiopaque, e.g., magnesium alloy, may be enhanced and madex-ray visible with the addition of x-ray visible materials, such asparticles of iron oxide, stainless steel, titanium, tantalum, platinum,or any other suitable equivalents. Further, the materials discussedbelow with respect to the shunts can also be used to form and/or coatthe tubular body 311, 312, 411, and 412, including non-permeablematerials, such as polyethylene terephthalate and polyvinylidenechloride, and semi-permeable materials, such as polylactide.

While various techniques can be used to deploy and actuate the devices10, 310, and 410, such as techniques disclosed in the '131 Application,in one exemplary embodiment an anastomotic device 10′′, which is of asimilar nature as anastomotic device 10, is removably coupled to anactuator that can be adapted to guide the device 10′″ into a body lumenand to apply an axial and rotational force to an elongate tubular body12′ to cause the elongate tubular body 12′ to extend outwardly. FIGS.16-25 illustrate one exemplary embodiment of an actuator 200 fordeploying the anastomotic device 10′″. In general, the actuator 200includes a proximal portion in the form of a handle 222 and an elongateshaft extending distally from the handle. A distal end of the actuator200 includes a digital gripper assembly 228 that is adapted to removablycouple to the anastomotic device 10′″. The elongate shaft includes anouter shaft or former 224 that is disposed around and coupled to anassembly shaft 225, which itself is disposed around an inner shaft 226.The inner shaft 226 is effective to hold a portion of the device 10′″ ina fixed position by expanding the assembly shaft 225 (and possibly alsothe former 224) to allow the digital gripper assembly 228, which isformed on the distal end of the assembly shaft 225, to engage the device10′, as described further below. With both the inner and assembly shafts226, 225 disposed within the former 224, the former 224 can be effectiveto apply axial and/or rotational forces to the anastomotic device 10′″to deploy the anastomotic device 10′″.

The former 224 can have a variety of configurations, but it ispreferably adapted to detachedly couple to a proximal end 10 a′″ of theanastomotic device 10′″. While various techniques can be used to couplethe former 224 to the anastomotic device 10, FIGS. 17 and 18 illustrateone exemplary technique. As shown, the former 224 includes one or moreprotrusions 224 a that can extend into one or more notches formedbetween tabs 15 a′″ formed in the proximal end 10 a′″ of the device 10′″such that the protrusions 224 a and tabs 15 a′″ interlock. Similarly,the digital gripper assembly 228 can also have a variety ofconfigurations, but it is shown as an expandable tubular member havingone or more protrusions 228 b that can extend proximally into one ormore notches formed between tabs 15 a′″ formed in the proximal end 10a′″ of the device 10′ such that the protrusions 228 b and tabs 15 a′″interlock. The distal gripper assembly 228 can be attached to or formedon the distal end of the assembly shaft 225, which is slidably disposedthrough the former 224. For example, the distal gripper assembly 228 canbe attached to the anastomotic device 10′″ using a threaded attachment.Furthermore, the distal gripper assembly 228 can include one or morethinned or weakened regions to help it collapse for its detachment andremoval from the outer elongate body 12 as described further below. Thethinned or weakened region(s) can be achieved by reducing the amount ofmaterial at that region, or by scoring or otherwise removing some of thematerial used to form the distal gripper assembly 228.

The former 224 and/or the assembly shaft 225 can also be configured toprovide maximum flexibility during clinical use, while the inner shaft226 can be rigidly configured to provide structural support to theformer 224 and/or the assembly shaft 225. For example, the former 224and/or the assembly shaft 225 can be formed from a flexible material, orthe former 224 and/or the assembly shaft 225 can include one or moreflexible regions formed thereon.

In order to rotate the former 224 relative to the assembly shaft 225 andthe inner shaft 226 and thereby form wings 16 a′″, 16 b′″, the handle222 of the actuator 220 can optionally include an actuation mechanismformed thereon. In an exemplary embodiment shown in FIGS. 19-22, thehandle 222 includes an outer collar 236 that can be coupled to aproximal portion of the former 224 such that rotation of the collar 236is effective to rotate the former 224. The proximal end of the assemblyshaft 225 can also include an inner collar 237 that is attached to theassembly shaft 225 and that includes a pin 240 formed thereon orextending therefrom. The pin 240 extends through and is positionedwithin the guide tracks 238. Since the position of the pin 240 is fixeddue to the assembly shaft 225 being fixed, movement of the outer collar236, and thus the former 224, is governed by the configuration of theguide tracks 238 which can move relative to the fixed pin 240. As aresult, the guide tracks 238 can be used to control the axial androtational forces applied to the anastomotic device 10′″ coupled to thedistal end of the former 224.

As shown in FIGS. 20-22, the guide tracks 238 can have a configurationthat allows the collar 236 to rotate in a first direction, e.g., counterclockwise, to deploy the distal wings 16 b′″ of the anastomotic device.The distal wings 16 a′″, 16 b′″ can be deployed before or after theproximal wings 16 a′″, although they are deployed first in this example.In particular, as the outer collar 236 is rotated counter clockwise, theformer tube 224 will rotate in a counter-clockwise direction, therebyrotating the proximal end 10 a′″ of the anastomotic device 10′″ toexpand the distal wings 16 b′″ of the anastomotic device 10′″. Thegripper 228 will remain in a fixed position, thus holding the distal end10 b′″ of the device 10′″ in a fixed position while the proximal end 10a′″ is rotated. As previously discussed, since slits 14 a′″, 14 b′″ indistal and proximal portions 12 a′″, 12 b′″ preferably extend inopposite directions, rotation of the anastomotic device 10′″ in a firstdirection will only deploy the distal wings 16 b′″. Once the outercollar 236 is fully rotated, the guide tracks 238 can allow distalmovement of the outer collar 236, while the guide pin 240 remains in afixed position at all times, thus allowing the outer collar 236 to beadvanced distally. As a result, the former tube 224 will applycompressive forces on the anastomotic device 10′″, thereby causing thedistal wings 16′″ to collapse into a substantially planer configuration.

The guide tracks 238 can then allow the outer collar 236 to rotate in anopposite direction, e.g., a clockwise direction, to cause the formertube 224 to rotate clockwise. As the former 224 rotates clockwise, theproximal wings 16 a′″ will expand. Once the outer collar 236 is fullyrotated, the guide tracks 238 can allow distal movement of the outercollar 236 therein, thus allowing the outer collar 236 to be advanceddistally. As a result, the former tube 224 will apply compressive forceson the anastomotic device 10′″, thereby causing the proximal wings 16a′″ to collapse into a substantially planar configuration in which theyextend transverse to the axis A (see FIG. 1) of the device 10′.

A person skilled in the art will appreciate that the guide tracks 238can have a variety of other configurations. For example, rather thanallowing rotation, and then distal movement, the guide tracks 238 canextend at an angle around the handle 222 to allow rotational andcompressive forces to be simultaneously applied to the anastomoticdevice 10′″. A person skilled in the art will appreciate that a varietyof other techniques can be used to actuate the former 224 to deploy thedevice.

Once the device 10′″ is deployed, the actuator 200 can be removed. Forexample, the distal gripper assembly 228 can be configured such that itcan disengage from the outer elongate body 12′″ when a force is appliedthereto. In use, the distal gripper assembly 228 can be collapsed byremoving the inner shaft 226, which allows the distal gripper assembly228 to return to an unexpanded state in which it can be retractedthrough the device 10′″. During use, the distal gripper assembly 228 canbe rotated relative to the anastomotic device 10′″ so as to unscrew thedistal gripper assembly 228 from the anastomotic device 10′″. Oncedetached, the distal gripper assembly 228 (and former 224) can beremoved from the patient, leaving the anastomotic device 10′″ inposition at the anastomotic site. A person skill in the art willappreciate that a variety of mating techniques can be used, including,for example, an interference fit, a mechanical interlock, etc.

FIGS. 23-25 illustrate a distal portion of the outer shaft 224, theassembly shaft 225, and the inner shaft 226 of the actuator 200 in usewith the anastomotic device 10′″. Following deployment of theanastomotic device 10′″, the actuator 200 is preferably disconnected andremoved from the patient. In FIG. 23, the protrusions 224 a on theformer 224 are removed from the corresponding cut-outs formed betweenthe tabs 15 a′″ in the proximal end 10 a′″ of the device 10′″. The innershaft 226 can then be withdrawn from the assembly shaft 225 and theouter shaft 224 in a distal direction. Removing the inner shaft 226 cancause the distal end of the assembly shaft 225 to collapse inwards asshown by the directional arrows in FIG. 24. The diameter of the assemblyshaft 225 can thereby be reduced so that it and the attached or coupleddistal gripper assembly 228 can be moved through the anastomotic device10′″. The entire remaining actuator assembly (e.g., the assembly andouter shafts 225, 224) can be withdrawn in a distal direction as shownin FIG. 25, thereby leaving the device 10′″ deployed and engagingtissue. The device 10′″ can also be removed from the body afterdeployment, if necessary. For example, the wings 16 a′″, 16 b′″ can becollapsed to their original, flat, undeployed configuration and thedevice 10′″ can be removed from the body.

FIGS. 26-30 illustrate another technique that can be used to deploy andactuate the devices 10, 310, and 410. For example, anastomotic device 10can be removably coupled to an actuator that is similar to actuator 200.The actuator can include an elongate shaft extending from a handle andthe elongate shaft can include an outer shaft or former 224′. Former224′ has a configuration that is similar to the configuration of former224 except that the digital gripper assembly 228 is replaced by anelongated tubular body 229′. Former 224′ can be effective to apply axialand/or rotational forces to the anastomotic device 10 to deploy theanastomotic device 10. A distal end of the elongated tubular body 229′can be coupled to a proximal end 10 a of the device 10 in a variety ofways, some of which are discussed above with respect to the gripperassembly 228. Similarly, the elongated tubular body 229′ can also have avariety of configurations. As shown, an inner tube 225′ can be disposedin the elongated tubular body 229′. The inner tube 225′ can include oneor more notches formed between tabs 230′ formed in a distal end 225 b′of the inner tube 225′ such that the notches and the tabs 15 a formed inthe proximal end 10 a of the anastomotic device 10 can interlock. Theinner tube 225′ can be coupled to the elongated tubular body 229′ in avariety of ways, but in one exemplary embodiment illustrated best inFIGS. 27 and 28, it is connected axially with the tubular body 229′using one or more sutures 231′. The sutures 231′ can be at leastpartially disposed in the tube 225′ and the free ends can be attached toan actuator. The sutures 231′ can be configured to hold the anastomoticdevice 10 to the former 224′ and the inner tube 225′. Although portionsof the anastomotic device 10 can be configured to rotate, in use thesutures 231′ can be configured such that they generally do not rotatebecause of the notches and tabs coupling the device 10, former 224′, andinner tubes 225′. The sutures 231′ can be configured to experiencetensile forces though, for example, when the former 224′ appliescompressive forces. FIG. 28 illustrates one instance in which the wings16 a, 16 b of the anastomotic device 10 have been deployed and theformer 224′, inner shaft 225′, and sutures 231′ each remain intact. Asshown in FIG. 29, the sutures 231′ can be removed, for example bymanually removing them from the outside or by using a mechanism forsuture removal incorporated with the actuator. As shown in FIG. 30, theanastomotic device 10 can be de-coupled from the former 224′ and innertube 225′ using a variety of different methods, including thosediscussed with respect to the former 224.

FIGS. 31-35 another technique that can be used to deploy and actuate thedevices 10, 310, and 410. For example, anastomotic device 10 can beremovably coupled to an actuator that is similar to actuator 200. Theactuator can include an elongate shaft extending from a handle and theelongate shaft can include an outer shaft or former 224″. Former 224″has a configuration that is similar to the configuration of former 224except that the digital gripper assembly 228 is replaced by an elongatedtubular body 229″. Former 224″ can be effective to apply axial and/orrotational forces to the anastomotic device 10 to deploy the anastomoticdevice 10. A distal end of the elongated tubular body 229″ can becoupled to a proximal end 10 a of the device 10 in a variety of ways,some of which are discussed above with respect to the gripper assembly228. Similarly, the elongated tubular body 229″ can also have a varietyof configurations. As shown, an inner tube 225″ can be disposed in theelongated tubular body 229″. In one embodiment the elongated tubularbody 229″ and the inner tube 225″ can include features that allow themto couple together to hold the inner tube 225″ in a desired location.For example, the inner tube 225″ can include one or more protrusions 225a″ configured to engage with one or more slots 229 a″ of the elongatedtubular body 229″ to hold the inner tube 225″ in a variety of locations.In a first position of the inner tube 225″, the protrusions 225 a″ canhave a small cone angle and they can be disposed within the slots 229 a″by pushing a tubular body 231″ disposed within the tubular body 229″,thereby locking the tubular body 229″ in a desired location.Accordingly, as illustrated in FIG. 33, as the anastomotic device 10 isdeployed, the former 224″, the inner tube 225″, and the elongatedtubular body 229″ can remain intact while the wings 16 a, 16 b of thedevice 10 are deployed. The protrusions 225 a″ can also be disengagedfrom the slots 229 a″, as illustrated in FIG. 34, by pulling in adirection R on the elongate tubular body 229″. A shown in FIG. 35, theanastomotic device 10 can be decoupled from the former 224″, the innertube 225″, and the tubular body 229″ using a variety of differentmethods, including those discussed with respect to the former 224.

FIGS. 36-38 illustrate yet another technique that can be used to deployand actuate the devices 10, 310, and 410. For example, anastomoticdevice 410 can be removably coupled to an actuator that is similar toactuator 200. The actuator can include an elongate shaft extending froma handle and the elongate shaft can include an outer shaft or former224″. Former 224′ has a configuration that is similar to theconfiguration of former 224 and it can be effective to apply axialand/or rotational forces to the anastomotic device 410 to deploy theanastomotic device 410. A distal end 224 b′″ of the former 224′″ can becoupled to a proximal end 412 a of the tubular body 412 of the device410 in a variety of ways, some of which are discussed above with respectto former 224. As shown, the distal end 224 b′″ of the former 224′″ caninclude one or more notches formed between tabs 230′″ such that thenotches and the tabs 423 formed in the proximal end 412 a of the tubularbody 412 of the anastomotic device 410 can interlock. As shown in FIG.37, an inner tube 225′″ can be disposed in the actuator and the tubularbody 411 can be attached thereto while the former 224′″ can be coupledwith the proximal end 412 a of the tubular body 412. The anastomoticdevice 410 can be deployed while the former 224′″ and the inner tube225′″ are still coupled to the tubular body 412, as shown in FIG. 38.

FIGS. 39-42 illustrate still another technique that can be used todeploy and actuate the devices 10, 310, and 410, which uses a forcerelease mechanism 470. For example, anastomotic device 10 can beremovably coupled to an actuator that is similar to actuator 200. Theactuator can include an elongate shaft extending from a handle and theelongate shaft can include an outer shaft or former 224″. Former 224″has a configuration that is similar to the configuration of former 224except that the digital gripper assembly is replaced by a forcedejection mechanism 470, which is disposed through former 224″ andcoupled to the anastomotic device 10. Former 224″ can be effective toapply axial and/or rotational forces to the anastomotic device 10 todeploy the anastomotic device 10. A distal end of former 224″ can becoupled to a proximal end 10 a of the device in a variety of ways, someof which are discussed above with respect to the gripper assembly 228.As illustrated by FIGS. 40 and 41, the forced ejection mechanism 470 caninclude a tubular body 472 that is configured to couple to the distalend 10 b of the anastomotic device 10. In one embodiment a distal end472 c of the tubular body 472 is welded to the distal end 10 b of theanastomotic device 10. Further, a proximal end 472 a of the tubular body472 can be coupled to a proximal end of a body portion 474, for exampleby welding. As shown the body portion 474 is cylindrical, although othershapes that generally fit well with the shape of the anastomotic devicecan be used. In the illustrated embodiment, the body portion 474includes one or more perforations 475 that can allow a contrast mediumto pass therethrough. In other embodiments the body portion 474 can besolid. An elongate member 476 can be coupled to the body portion 474. Inthe illustrated embodiment, a center portion of the body portion 474includes a hole that is configured to receive the elongate member 476and the elongate member 476 is fit into the hole, for example by weldingor press-fitting the elongate member 476 within the hole. In oneembodiment the elongate member 476 is hollow to allow fluid, such ascontrast medium, to pass through or to allow a guidewire to passtherethrough such that the elongate member 476 can slide along theguidewire. The elongate member 476 can be made of a variety ofmaterials, including nitinol, stainless steel, titanium, or a variety ofbio-compatible materials. A mid-portion 472 b of the tubular body 472can include a breaking boundary 478 that is configured to allow theproximal end 472 a to separate from the distal end 472 c of the tubularbody 472. This can occur before or while the former 224″ is beingseparated from the anastomotic device 10. In one exemplary embodimentthe breaking boundary 478 is patterned by a laser cut. The shape of thebreaking boundary 478 can be any number of shapes that are configured toapply rotational force and withstand a specified axial force. Thebreaking boundary 478 can break when the axial force exceeds thespecified limit. Specifically, the size, shape, and design of thebreaking boundary can be altered to achieve a desired breaking force. Asshown in FIG. 42, a breaking force can be applied to the tubular body472, which can decouple the anastomotic device 10 from the former 224″such that the proximal end 472 a of the tubular body 472 and the former224″ can be removed from a placement site, thereby leaving the deployedanastomotic device 10 and a distal end 472 c of the tubular body 472 atthe placement site. The distal end 472 c of the tubular body 472 can beconfigured to allow fluid to pass therethrough, or alternatively, it canbe removed. Further, although the tubular body 472 is discussed as beingtubular, a person having ordinary skill in the art would recognize thatother shapes can also be used for the body 472.

As indicated above, the methods disclosed herein for forming a bypasscan also include forming a surrogate pathway between a patient'sesophagus and an anastomosis formed between the patient's stomach andintestine. The surrogate path allows fluid to at least partially bedirected from the esophagus to the intestine through a connection formedbetween a patient's stomach and a portion of a patient's intestine. Thesurrogate path can be formed using any device or combination of devicesthat is configured to redirect fluid, generally referred to herein as ashunt. Some examples of shunts that can be used to form a surrogate pathinclude a simple tube, catheter, stent, or any elongate member. Theshunt is generally configured to form a surrogate path to bypass atleast a portion of a patient's stomach, up to the entire stomach. In oneexemplary embodiment, the shunt extends between a patient's esophagusand an anastomosis formed between the patient's stomach and theintestine (i.e., a gastro-entero anastomosis) to bypass a patient'sstomach completely. The shunt can include a proximal end configured toreceive fluid from the esophagus and a distal end configured to directfluid to a patient's intestine. The shunt can be configured to couplewith or pass through an anastomotic device, or alternatively, it can beintegrally formed with an anastomotic device. A variety of anastomoticdevices, including the devices 10, 310, and 410, can be configured tocouple with the shunt or be integrally formed with the shunt.Optionally, the shunt can include a one-way valve configured to inhibitacid reflux. While capable of inhibiting acid reflux, the one-way valveis also preferably configured to allow the flow of fluid back throughthe shunt if induced by an action such as regurgitation. One way ofconfiguring the one-way valve to resist fluid from flowing back up theshunt because of acid reflux but allowing fluid from flowing back up theshunt because of regurgitation is by setting a threshold pressure of theone-way valve to resist opening based on pressure exerted on the valvetypical of acid reflux and opening based on the pressure exerted on thevalve typical of regurgitation. The shunt can optionally be porous toallow some fluid to dissipate through the shunt and into the stomach,but preferably the shunt is non-porous.

One exemplary embodiment of a shunt is illustrated in FIG. 43. The shuntis a linear-shaped shunt 50 that includes a proximal end 50 p configuredto receive fluid and a distal end 50 d configured to direct fluid in asingle direction. As illustrated, the linear-shaped shunt 50 isintegrally formed with an anastomotic device 60 to form a combinationshunt and anastomotic device, although in alternative embodiments theshunt and anastomotic device can be separate. The linear-shaped shunt 50is configured to extend from an esophagus, through a stomach, and intoan intestine of a patient via a gastro-entero anastomosis. In otherembodiments, for instance where the shunt is not configured to extendall the way between the esophagus and the intestine, the shunt caninclude a separate tube configured to couple to the proximal or distalend of the shunt. In use, the distal end 50 d of the linear-shaped shunt50 can be configured to direct fluid in a single direction. For example,it can direct fluid through the anastomosis toward a distal portion ofthe intestine, as will be discussed in more detail below.

In another exemplary embodiment, illustrated in FIG. 44, the shunt canbe a Y-shaped shunt 70 that includes a proximal end 70 p configured toreceive fluid and a distal end 70 d configured to direct fluid in twodirections. As illustrated, the Y-shaped shunt 70 is integrally formedwith an anastomotic device 80 to form a combination shunt andanastomotic device, although in alternative embodiments the shunt andanastomotic device can be separate. In particular, the distal end 70 dof the shunt 70 is Y-shaped to allow a first leg 72 to extend in a firstdirection, i.e., toward a proximal portion of the intestine, and toallow a second leg 74 to extend in a second opposite direction, i.e.,toward a distal portion of the intestine. Allowing fluid flow in bothdirections can be advantageous because it allows more vitamins,minerals, and nutrients to be absorbed by the intestine since theproximal portion of the intestine is not completely bypassed.

The shunt can be formed from a variety of materials depending on thedesired capabilities of the shunt. For example, the shunt can be formedof a non-permeable polymer, such as polyethylene terephthalate, so thatfluid that flows therethrough does not penetrate through the device andinto the stomach. Non-permeability can also be achieved by way of anon-permeable coating, such as polyvinylidene chloride. Alternatively,it can be desirable to allow some fluid to dissipate into the body, inwhich case a semi-permeable polymer, such as polylactide, can be used toform the shunt or to form a coating for the shunt. Forming the shuntfrom a semi-permeable polymer can allow vitamins, minerals, andnutrients found in fluid to dissipate into the stomach. Other materials,such as those suitable for forming an anastomotic device as discussedabove, can also be used to form a shunt. Similarly, materials which arenot normally radiopaque, e.g., magnesium alloy, may be enhanced and madex-ray visible with the addition of x-ray visible materials, such asparticles of iron oxide, stainless steel, titanium, tantalum, platinum,or any other suitable equivalents. It can also be desirable to configurethe shunt such that it can expand. Materials can be selected to form theshunt that have expandable properties, such as elastomeric polymers. Insome embodiments the shunt can be designed to be self-expanding,balloon-expandable, rigid-covered, or open-framed.

In an exemplary embodiment, a method for treating obesity generallyentails forming a fluid connection between a stomach and an intestineand forming a surrogate path from an esophagus to the intestine so fluidis at least partially directed from the esophagus to the intestinethrough the connection, thereby at least partially bypassing thestomach. The method can also include forming a connection between twoportions of the intestine—one portion distal to the fluid connectionbetween the stomach and the intestine and one portion proximal to thefluid connection between the stomach and the intestine—to form a singleintestine loop. The connections between the stomach and the intestineand the two portions of the intestine can be formed in any order. Thesurrogate path can extend to one or both of the proximal and distalportions of the intestine. At either or both of the connections, ananastomotic device can be disposed therein, such as the device 10previously described herein. Further, the surrogate path can be formedby inserting a shunt through the anastomotic device at the connectionbetween the stomach and the intestine, or alternatively, the surrogatepath can be formed by implanting an anastomotic device having a shuntintegrally formed thereon. Either or both of the anastomotic device andthe shunt can be delivered to desired locations using a variety oftechniques, including, by way of non-limiting examples, those discussedherein and those discussed in the '131 Application.

In one exemplary embodiment for treating obesity, illustrated in FIGS.45A-45F, a gastric bypass procedure is performed that includes forming aconnection (i.e., an entero-entero anastomosis 110) between two portions150 a, 150 c of an intestine 150 prior to forming a connection (i.e., agastro-entero anastomosis 120) between a stomach 140 and a portion ofthe intestine 150 located between the two portions 150 a, 150 c. In anexemplary embodiment the procedure can begin by inserting an endoscopein the body using a natural body orifice in accordance with NOTESprocedures. Using natural body orifices to perform the procedure isgenerally preferred because it obviates the need for any additionalincisions in the abdominal wall, intestine, or in any other part of thebody beyond those needed to form anastomoses. Nevertheless, laparoscopicmethods can also or alternatively be used. If using a laparoscopicmethod, a trocar assembly can be inserted into the surgical site, e.g.,the stomach, at any number of locations in the stomach, including theepigastrium, the flank, and the mesogastrium.

As illustrated in FIG. 45A, an endoscope 100 is inserted into anesophagus 130 transorally. The endoscope 100 can travel through theesophagus 130, through the pylorus 142, and to a desired location in thestomach 140. A cutting device either associated with the endoscope 100or inserted through the endoscope can be used to form an opening 146through the stomach 140 wall. The cutting device can be any deviceconfigured to cut tissue, such as a needle or knife. Further, a secondopening 156 can be formed in a distal portion of an intestine 160. Thiscan be achieved by advancing the endoscope, or at least the cuttingdevice, through the opening 146 and toward the intestine 160. Theintestine 160 may need to be grasped and manipulated using graspers orother tools inserted laparoscopically, e.g., through a trocar cannula,through the abdominal wall and into the peritoneal cavity. The opening156 in the intestine 160 can optionally be formed at the same time thatthe opening 146 in the stomach 140 is formed by positioning theintestine 160 adjacent to the stomach 140.

After forming the openings 146, 156 in the stomach 140 and the intestine150, the endoscope 100 can continue through the intestine 150 to formopenings 154, 158 in the portions 150 a, 150 c of the intestine 150proximal and distal to opening 156, respectively, as shown in FIG. 45B.The endoscope 100, or at least a cutting device, can be directed to adesired location either toward the proximal or distal portion 150 a, 150c of the intestine 150, and once the desired location is reached, thecutting device can be used to form openings 154, 158 in the respectiveproximal and distal portions 150 a, 150 c of the intestine 150. This mayrequire one or more additional instruments be disposed in the body,e.g., laparoscopically, so that the proximal and distal portions 150 a,150 c of the intestine 150 can be moved adjacent to each other. Similarto the formation of the openings 146, 156, the openings 154, 158 in theproximal and distal portions 154 a, 154 c of the intestine 150 can beformed at the same time, or alternatively, subsequent to each other. Theformation of the two openings 154, 158 allows for the entero-enteroanastomosis 110 to be formed. The entero-entero anastomosis 110 forms apathway through which fluid can travel, and further, the formation ofthe entero-entero anastomosis 110 forms a loop 160 of the intestine 150.

Once the entero-entero anastomosis 110 is formed, an anastomotic devicecan be implanted between the two openings 154, 158. For example,anastomotic device 10′ described above can be inserted through the mouth(not pictured), through the esophagus 130, through the stomach 140,through the openings 146, 156 in the stomach 140 and the intestine 150,respectively, through either the proximal or distal portions 150 a, 150c of the intestine 150, and into the openings 154, 158. FIG. 45Cillustrates the anastomotic device 10′ disposed in the entero-enteroanastomosis 110. In one exemplary embodiment the anastomotic device 10′is implanted by coupling the anastomotic device 10′ to a delivery shaftwhich can be inserted through the endoscope 100 to position the device10′ between the two openings 154, 158, and to deploy the device 10′ toengage the tissue surrounding the openings 154, 158 therebetween,thereby forming a pathway between the openings 154, 158. The anastomoticdevice 10′ can also be delivered in a number of other different ways,such as, by way of non-limiting example, those discussed above withrespect to the actuator 200 and other methods disclosed in the '131Application.

After completing the entero-entero anastomosis 110, the endoscope 100can be retracted back to the stomach 140 as shown in FIG. 45D. If theopening 156 in the intestine 150 is not adjacent to the opening 146 ofthe stomach 140, one or more instruments may be used to manipulate theintestine 150 to position the openings 146, 156 in alignment tofacilitate the formation of the gastro-entero anastomosis 120. Aspreviously indicated and as illustrated in FIG. 45D, a grasping tool 170can be inserted into the body laparoscopically to grasp the intestine150 and direct it to the desired location with respect to the stomach140. In another embodiment a guide cable can be passed through orcoupled to the intestine and the guide cable can subsequently be movedto guide the intestine to the desired location. Once the openings 146,156 are adjacent to each other, the gastro-entero anastomosis 120 can beformed, e.g., using a second anastomotic device 10″ deployed between thetwo openings 146, 156. The anastomotic device 10″, which is similar tothe anastomotic device 10 described above, can be inserted through themouth (not pictured), through the esophagus 130, through the stomach140, and into the openings 146, 156 of the stomach 140 and the intestine150, respectively. FIG. 45E illustrates the anastomotic device 10″disposed in the gastro-entero anastomosis 120. The device 10″ can bedeployed as previously explained. Deploying the anastomotic device 10″forms a pathway through which fluid can travel.

While the delivery of the anastomotic devices 10′, 10″ can be doneseparately, a single device can be used for delivering both anastomoticdevices 10′, 10″ such that first the entero-entero anastomotic device10′ is delivered to form the entero-entero anastomosis 110 and then, asthe device for delivering the anastomotic devices 10′, 10″ is retractedinto the stomach, the gastro-entero anastomotic device 10″ is deliveredto form the gastro-entero anastomosis 120. Once the procedure iscomplete, the endoscope 100 and other tools can be removed, leaving aconfiguration of the stomach 140 and the intestine 150 as is illustratedin FIG. 45F. More specifically, the gastro-entero anastomosis 120 isformed between the stomach 140 and the intestine 150 and has theanastomotic device 10″ disposed therebetween and the loop 160 of theintestine 150 is formed between the proximal and distal portions 150 a,150 c of the intestine. The entero-entero anastomosis 110 has theanastomotic device 10′ disposed therebetween. This configuration allowsfluid to travel to the distal portion 150 c of the intestine: (a)directly from the gastro-entero anastomosis 120; (b) from thegastro-entero anastomosis 120, through the proximal portion 150 a of theintestine 150, and through the entero-entero anastomosis 110; and/or (c)from the stomach 140, through the proximal portion 150 a of theintestine 150, and through the entero-entero anastomosis 110.

In another embodiment, after the openings 146, 156 in the stomach 140and the intestine 150 are formed and prior to either forming theopenings 154, 158 in the proximal and distal portions 150 a, 150 c ofthe intestine 150 or deploying the anastomotic device 10′, thegastro-entero anastomosis 120 can be formed and the anastomotic device10″ can be deployed in the openings 146, 156. When forming thegastro-entero anastomosis 120 before forming the entero-enteroanastomosis 110, the endoscope 100 may need to be removed so that asecond endoscope can be inserted in a similar fashion as the endoscope100 was inserted and moved to a location for forming the entero-enteroanastomosis 110. The second endoscope can be sized to fit through theanastomotic device 10″, and thus is typically smaller than the firstendoscope 100. The second endoscope and related cutting device canperform similar functions at the location of the entero-enteroanastomosis 110 as the endoscope 100.

In still another embodiment, the openings 154, 158 in the proximal anddistal portions 150 a, 150 c of the intestine 150 can be formed prior toforming either of the two openings 146, 156 in the stomach 140 and theintestine 150, for example by performing the endoscopic proceduretransanally. In such an embodiment, first the entero-entero anastomosis110 can be formed and then the gastro-entero anastomosis 120 can beformed. Alternatively, the gastro-entero anastomosis 120 can be formedbefore the entero-entero anastomosis 110. A person skilled in the artwould understand how to apply the teachings described herein to engagein procedures for treating obesity which form the gastro-entero andentero-entero anastomoses in any order and beginning from any location.

The method can also include implanting a shunt to form a surrogate pathto allow fluid to pass from a patient's esophagus to a patient'sintestine through the gastro-entero anastomosis 120. The shunt can becoupled to the proximal end of the anastomotic device 10″ disposedbetween the stomach 140 and the intestine 150, or alternatively, it canconnect to or pass through the anastomotic device 10″ so that it candeliver fluid to either or both of the proximal and distal portions 150a, 150 c of the intestine 150. If coupled to the proximal end of theanastomotic device, the anastomotic device can be configured to deliverfluid to either or both of the proximal and distal portions 150 a, 150 cof the intestine 150. In one embodiment the shunt can be inserted priorto the formation of any anastomoses such that the shunt serves as achannel in which to perform the methods discussed herein. Uponcompletion of the formation of the anastomoses, the shunt can then becoupled to the proximal end of the anastomotic device located at thegastro-entero anastomosis. Insertion of the shunt can be done by way ofa delivery shaft having the shunt coupled thereto. The delivery shaftcan be inserted through the endoscope 100 and it can be manipulated toadvance the delivery shaft, and thus the shunt, to a desired location.This may involve manipulating the delivery shaft, and thus the deliverydevice, around a tortuous pathway.

FIG. 45G illustrates one embodiment of a shunt implanted to deliverfluid in a single direction to the distal portion of the intestine. Inthis embodiment, the shunt 50 of FIG. 43 is used, thus the anastomoticdevice 60 is formed integrally with the shunt 50. In order to implantthe shunt 50, the anastomotic device 60 is positioned in the openings146, 156 and deployed as explained above, and the proximal end 50 p ofthe shunt 50 is placed in communication with the esophagus while thedistal end 50 d of the shunt 50 is directed toward the distal portion150 c of the intestine 150. To assist with the delivery of thelinear-shaped shunt 50, the distal end 50 d can be configured to fold-upwhen disposed within an actuator, such as the actuator 200, orintroducer sheath such that a sleeve thereof can be retracted to allowthe distal end 50 d of the linear-shaped shunt 50 to expand into placeat a desired location. In the illustrated embodiment the distal end 50 dis configured to direct fluid toward the distal portion 150 c of theintestine 150, shown by the arrows T disposed therein. The arrows Sindicate the flow of fluid from the stomach 140 toward the entero-enteroanastomosis 110, which can include fluid that dissipates through theshunt if it is semi-permeable and fluid formed by the stomach, such asbile. Optionally, the distal end 50 d can be configured to direct fluidtoward the proximal portion 150 a of the intestine 150, which because ofthe entero-entero anastomosis 110, is eventually directed toward thedistal portion 150 c of the intestine 150.

FIG. 45H illustrates a method for directing fluid from the esophagusinto both the proximal and distal portions of the intestine using theY-shaped shunt 70 of FIG. 44. The Y-shaped shunt 70 includes ananastomotic device 80 integrally formed thereon that is disposed at thegastro-entero anastomosis 120. More particularly, the Y-shaped shunt 70is placed so that the anastomotic device 80 is disposed at thegastro-entero anastomosis 120, the proximal end 70 p of the Y-shapedshunt 70 is positioned to receive fluid from the esophagus 130, and thedistal end 70 d of the Y-shaped shunt 70 is positioned to direct fluidin two directions toward the intestine 150. To assist with the deliveryof the Y-shaped shunt 70, the distal end 70 d can be configured tofold-up when disposed within an actuator, such as the actuator 200, oran introducer sheath such that a sleeve thereof can be retracted toallow the distal end 70 d of the linear-shaped shunt 70 to expand intoplace at a desired location. In the illustrated embodiment the distalend 70 d is configured to direct fluid toward both the proximal anddistal portions 150 a, 150 c of the intestine, shown by the arrows R, T,respectively. The arrows S indicate the flow of fluid from the stomach140 toward the entero-entero anastomosis 110, which can include fluidthat dissipates through the shunt if it is semi-permeable and fluidformed by the stomach, such as bile. The fluid flowing toward theproximal and distal portions 150 a, 150 c will eventually flow towardthe distal portion 150 c of the intestine because the entero-enteroanastomosis 110 causes the fluid flowing toward the proximal portion 150a to be directed to the distal portion 150 c.

Upon the formation of either or both of the gastro-entero anastomosisand the entero-entero anastomosis, a seal test can be performed toinsure that the connection between the two body components is secure.For example, in one embodiment one or more instruments for introducing amaterial into the anastomosis to test the seal between the two bodycomponents can be introduced. By way of a non-limiting example, thematerial can be methalyene blue. The methalyene blue can enter theanastomosis and the one or more instruments can allow an operatoroutside of the body to visualize whether the methalyene blue passesthrough the anastomosis without leaking into the stomach.

The methods and procedures discussed herein can also be altered orreversed. Thus, if after the procedures are performed a patient ishaving any difficulties, an operator can easily alter the procedure.Alterations of the procedure can include, but are not limited to,adjustments to the size, shape, material, type, and location of any ofthe shunt, the anastomotic devices, or any other instruments or toolsthat were used as part of the procedure. Likewise, if it is determinedthat a patient no longer needs the gastric bypass, the bypass can beremoved. In one exemplary embodiment, the gastric bypass is removed byeliminating the surrogate path. This can be accomplished by removing theshunt from the system. The anastomoses can optionally remain, as removalof the shunt allows fluid to enter the stomach through the esophagus andbe digested through the entero-entero anastomosis. This is a significantimprovement over current procedures in which stapling off the stomachgenerally prevents the stomach from being used at a later period intime. While the anastomoses can remain, they can also be removed byremoving the anastomotic devices and/or patching the openings throughwhich the anastomotic devices were disposed.

By forming a gastro-entero anastomosis, fluid can pass from theesophagus, to the intestine, without entering the stomach. This allowsfood to be digested quicker and allows a patient to eat less. A patienteats less because receptors located in the wall of the stomach areadapted to sense the location of fluid, and based on the location offluid, can signal to a patient's brain that the patient is full. It isthe receptors that communicate hunger to a patient. A patient still getsenough fluid because the shunt can be configured to expand to allowenough fluid to enter the body to get enough vitamins, minerals, andnutrients to the patient. Because this procedure is adjustable andreversible, adjustments can be made to optimize the system for eachindividual patient. Further, the loop created by forming theentero-entero anastomosis provides multiple benefits. In embodiments inwhich the shunt is configured to deliver fluid in multiple directions,i.e., to the proximal and distal portions of the intestine, allowing theproximal portion to receive fluid from the shunt enables additionalvitamins, minerals, and nutrients from the fluid to be absorbed by thebody. Further, although the stomach is being bypassed by the shunt, insome embodiments the device can be semi-permeable, which means thatfluid that dissipates through the shunt and into the stomach still has apathway to enter the intestine. Still further, cells of a patient'sstomach and liver generally produce a fluid, e.g. bile to digest food,so by forming the loop the fluid has a pathway to enter the intestine.Not providing a pathway for the fluid to exit the stomach can lead toother medical complications, such as a bowel obstruction.

Anastomotic devices such as devices 10, 310, and 410 can also be used inother types of procedures beyond gastric bypass procedures. While someof these types of procedures are discussed in more detail in the '131Application, in one embodiment the device 410 is used in conjunctionwith an endovascular graft for repair of an abdominal aortic aneurysm,as shown in FIGS. 46 and 47. The device 410 can be attached to ananeurysm graft 500 in a number of different ways, but in the illustratedembodiment a fenestration (not pictured) is formed in the aneurysm graft500 and a dome 502 is placed or formed over the fenestration. The device410 can be attached to the fenestration within the dome 502 usingconventional mating techniques known in the art. The dome 502 can beconstructed from a variety of materials, including materials that areboth different and the same as the materials used to form the aneurysmgraft 500. In one embodiment the aneurysm graft 500 and the dome 502 areformed of a biomaterial. The dome 502 provides maneuverability foraccurate association of the device 410 with the aneurysm graft 500. Forexample, if the aneurysm graft 500 is used to treat a juxtarenal aorticaneurysm, the dome 502 can allow an operator the ability to findasymmetrical arteries, such as one or more renal arteries 504 attachedto an aorta 506 having an aneurysm 507. Renal arteries 504 can be atdifferent levels and in different planes with respect to the aorta 506,thus making accurate association between the device 410, the graft 500,and the renal arteries 504 difficult. The dome 502 can assist theoperator in finding the renal arteries 504 and aligning the endovasculargraft 500 with the renal arteries 504 for placement of a vascularconduit, such as covered stent 508, across the endovascular graft 500into these branching arteries 504. Presently, location of suchasymmetrical renal arteries 504 requires the construction of acustomized fenestrated graft which is manufactured following extensivepre-planning using imaging technologies such as CAT and MRI scans. Thedome 502, however, can allow for off-the-shelf alignment of theendovascular graft 500 with side branch arteries 504 at variouspositions. Following alignment of the dome 502 in the endovascular graft500 with the target side branch artery 504, a flexible vascular graft,such as illustrated tubular body 411 disposed in renal artery 503, canbe anchored across the fenestration covered by the dome 502, for exampleby using wing technologies, illustrated as wings 416, as discussed withrespect to devices 10, 310, and 410. While presently discussed withrespect to the endovascular graft 500 being formed in the abdominalaorta position, it can also be used in other positions, for instance, ina thoracic aorta position. Likewise, while presently discussed withrespect accessing renal arteries 504, any branch of an artery associatedwith any length of the aorta can be accessed using the teachings of thepresent disclosure.

By way of further non-limiting example, another procedure in whichanastomotic devices such as devices 10, 310, and 410 can be used is tocinch tissues together. One example of this procedure is illustrated byFIGS. 48-49, in which a mitral annulus is cinched together to decreaseits circumference and correct a leaking mitral valve (mitralregurgitation). As shown, a mitral valve 602 includes an anteriorleaflet 604 and a posterior leaflet 606. The anterior and posteriorleaflets 604, 606 are attached to an annulus 608. More specifically, theanterior and posterior leaflets 604, 606 are attached to a fibrousskeleton of a heart at an anterior annulus 610 and to a left ventricleat a posterior annulus 612. The leaflets 604, 606 are connected,primarily at their tips, by a chordae tendinae to papillary muscles,which originate from the left ventricle. Thus, the mitral apparatus iscomplex. Changes in one or a combination of its components can lead tosignificant mitral regurgitation, resulting in left ventricular dilationand worsening valvular incompetence. When there is disease of theleaflets 604, 606, most commonly due to myoxamatous degeneration, mitralregurgitation is classified as primary. When there is remodeling of theleft ventricle but the leaflets 604, 606 are normal, mitralregurgitation is classified as secondary or functional.

Percutaneous repair of functional mitral regurgitation involves movingthe posterior annulus 612 towards the anterior annulus 610 to increaseleaflet 604, 606 coaptation. This may be achieved using anastomoticdevices such as devices 10, 310, and 410. In the embodiment illustratedin FIG. 48, the device 410 is passed into tissue proximal to the annulus608 of the mitral valve 602 of a heart 600 of a patient. For referencepurposes, as illustrated, the heart 600 includes a pulmonary valve 601,a tricuspid valve 603, and an aorta 605. This can allow the device 410to be placed circumferentially around the annulus 608 of the mitralvalve. For example, the device 410 can be passed through the posteriormitral annulus 612 either under direct vision as in open surgery orunder fluoroscopy (x-ray) control, or under echocardiography. Upondetermining that the device 410 is in the correct position, the wings416 a, 416 c can be formed and the tissue therebetween can be cinchedtogether. The allows a diameter of the mitral annulus 608 to decrease insize, which in turn results in coaptation of the mitral valve leaflets604, 606. Coaptation of the mitral valve leaflets 604, 606 can decreasethe amount of mitral regurgitation through the valve 602 during systolicbeating of the left ventricle. The degree of reduction of mitralregurgitation may be observed in real time during a percutaneousprocedure by using, for example, echocardiography. Once the desiredamount of coaptation of the leaflets 604, 606 is obtained, the deliverysystem used to deliver the device 410 can be disconnected from thedevice 410, as discussed with respect to other embodiments above.

Alternatively, as illustrated in FIG. 49, the device 410 can be passedacross the mid-portion of the posterior annulus 612′ and the anteriorannulus 610′ of the mitral valve 602′ of the heart 600′ of a patient andthe degree of reduction of mitral regurgitation for the mitral valveleaflets 604′, 606′ can be observed under echocardiography or otherimaging means in real time as the wings 416 a, 416 c are broughttogether. This can allow the device 410 to be placed transversallyacross the annulus 608′ of the mitral valve. For reference purposes, asillustrated, the heart 600′ includes a pulmonary valve 601′, a tricuspidvalve 603′, and an aorta 605′.

One skilled in the art will appreciate further features and advantagesof the invention based on the above-described embodiments. Accordingly,the invention is not to be limited by what has been particularly shownand described, except as indicated by the appended claims. Allpublications and references cited herein are expressly incorporatedherein by reference in their entirety.

1. An anastomotic device, comprising: a first tubular body having aproximal end and a distal end that is adapted to expand upon rotation toform distal wings; and a second tubular body having a distal endslidably coupled to the proximal end of the first tubular body and aproximal end that is adapted to expand upon rotation to form proximalwings that extend toward the distal wings to engage tissue therebetween.2. The device of claim 1, wherein the distal end of the first tubularbody and the proximal end of the second tubular body each include aplurality of asymmetrical substantially s-shaped slits formed therein.3. The device of claim 1, wherein the first and second tubular bodieseach include a lumen formed therethrough and configured to form apassageway through tissue.
 4. The device of claim 1, wherein the firstand second tubular bodies are each formed from a non-permeable material.5. The device of claim 1, wherein the first and second tubular bodiesform a shunt.
 6. The device of claim 5, wherein the shunt includes aproximal end adapted to receive a fluid and a distal end configured todirect fluid in a single direction.
 7. The device of claim 5, whereinthe shunt includes a proximal end adapted to receive a fluid and adistal end configured to direct fluid in a plurality of directions. 8.An anastomotic device, comprising: a first tubular body having a distalend adapted to expand upon rotation to form distal wings and an elongateproximal end; and a second tubular body having a proximal end adapted toexpand upon rotation to form proximal wings that extend toward thedistal wings of the first tubular body to engage tissue therebetween anda distal end adapted to be selectively positioned along the elongateproximal end of the first tubular body.
 9. The device of claim 8,wherein the distal end of the first tubular body and the proximal end ofthe second tubular body each include a plurality of asymmetricals-shaped slits formed therein.
 10. The device of claim 8, wherein thefirst and second tubular bodies each include a lumen foamed therethroughand configured to form a passageway through tissue.
 11. The device ofclaim 8, wherein the first and second tubular bodies are each formedfrom a non-permeable material.
 12. The device of claim 8, wherein thefirst and second tubular bodies form a shunt.
 13. The device of claim12, wherein the shunt includes a proximal end adapted to receive a fluidand a distal end configured to direct fluid in a single direction. 14.The device of claim 12, wherein the shunt includes a proximal endadapted to receive a fluid and a distal end configured to direct fluidin a plurality of directions.
 15. A method for repairing an abdominalaortic aneurysm, comprising: positioning a dome over a fenestration inan aorta to place an anastomotic device coupled to a first artery influid communication with a second artery disposed on the opposite sideof the aorta.
 16. The method of claim 15, further comprising placing avascular conduit having a fenestration in the aorta, the dome beingpositioned over the fenestration in the vascular conduit.
 17. A methodfor repairing a heart valve, comprising: positioning an anastomoticdevice within a tissue tract that includes a mitral valve having ananterior leaflet and a posterior leaflet, each of which is coupled to anannulus; deploying the anastomotic device to cause a diameter of theannulus to decrease and to enhance coaptation of the anterior andposterior leaflets.
 18. The method of claim 17, wherein positioning theanastomotic device within a tissue tract further comprises placing theanastomotic device circumferentially around the annulus of the mitralvalve.
 19. The method of claim 17, wherein positioning the anastomoticdevice within a tissue tract further comprises placing the anastomoticdevice transversally across the annulus of the mitral valve.